Hormonal Contraceptive Health Education for Adolescent Males

Contraception Behavior Clinical Trial

Official title:

Hormonal Contraceptive Health Education for Adolescent Males in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400410
• Other study ID #: 201706139
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective randomized control trial of an educational electronic application on female hormonal contraception for adolescent males in the pediatric emergency department.

Description:

Unintended pregnancy among adolescents is a significant public health issue and U.S. adolescents have one of the highest unintended pregnancy rates among industrialized nations. An estimated 9% of male adolescents becoming fathers by the time they are 20 years old. Over 14 million adolescents use emergency departments every year and many of the adolescent males that present to the ED are engaged in high risk sexual behaviors which puts them at high risk for unintended pregnancy. This presents an opportunity to educate males that are at high risk about pregnancy prevention.

This study is a prospective randomized control trial of education about female hormonal contraception for these higher risk adolescent males, 15-21 years old, that present to the Saint Louis Children's Hospital pediatric emergency department. An electronic application will be used to take a sexual history and ask questions about patients' current attitudes and use of hormonal contraception with their partners. They will then be randomized to watch a video on female hormonal contraception (experimental group) or no video (control group). The video will be an overview with brief pros and cons of all available types of hormonal contraception. The app emphasizes importance of condom use as part of dual method protection throughout. All patients will be followed up in 3 months to complete a survey with similar questions on sexual history, discussions with partners, and current contraceptive practices. The hypothesis of the study is that this will lead to increased rates of discussion about hormonal contraception between male adolescents and their sexual partners. This may lead to increased contraceptive use rates and a decrease in unintended pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 30, 2022
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 21 Years

Eligibility

Inclusion Criteria:

• Male adolescents 15-21 years of age that are sexually active and have ever had vaginal sex that present to the St Louis Children's Hospital pediatric emergency department.

Exclusion Criteria:

• Males that have never had vaginal sex

• Require activation of the trauma system

• Triage as high severity (level 1 or level 2)

• Present for evaluation of abuse, sexual assault, or psychiatric issues

• Unable to speak English

• Wards of the state

• Disabilities that prevent independent use of a tablet device

• Have not completed the electronic adolescent health questionnaire that is standard of care in our emergency department as this is needed for screening purposes

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

Behavioral:
• Education Arm
The educational video will be an overview with brief pros and cons of all types of available hormonal contraception. There will be emphasis on the importance of condom use as part of dual method protection.

Locations

Country	Name	City	State
United States	Washington Univeristy at St Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

Ahmad FA, Jeffe DB, Plax K, Schechtman KB, Doerhoff DE, Garbutt JM, Jaffe DM. Characteristics of youth agreeing to electronic sexually transmitted infection risk assessment in the emergency department. Emerg Med J. 2018 Jan;35(1):46-51. doi: 10.1136/emermed-2016-206199. Epub 2017 Aug 11. — View Citation

Centers for Disease Control and Prevention. Reproductive Health: Teen Pregnancy. http://www.cdc.gov/teepregnancy/about/index.htm. Accessed Sept 2016.

Mosher WD, Jones J, Abma JC. Intended and unintended births in the United States: 1982-2010. Natl Health Stat Report. 2012 Jul 24;(55):1-28. — View Citation

United Nations Population Fund. Adolescent Pregnancy: A Review of the Evidence. 2013; http://www.unfpa.org/publications/adolescent-pregnancy. Accessed Dec 2016, 2016.

Ziv A, Boulet JR, Slap GB. Emergency department utilization by adolescents in the United States. Pediatrics. 1998 Jun;101(6):987-94. doi: 10.1542/peds.101.6.987. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discussion rates	Discussion rates of male adolescents with partner(s) about hormonal contraception.	3 months
Secondary	Partner use of hormonal contraception	Partner use of hormonal contraception as assessed by male adolescent.	3 months
Secondary	Fatherhood	Rate of fatherhood of male adolescents in the study.	Baseline (at initial contact) and 3 months
Secondary	Male value of partner discussion and hormonal contraceptive knowledge	Yes or No question. Do they believe that partner discussion is important and do they believe that male knowledge of hormonal contraception is important.	3 months